MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Macular Edema (1822)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that after an intraocular lens (iol) implantation procedure, they have 3 or 4 cases of irvine gass macular edema in patients implanted with lenses.Additional information was requested and received ,patient details were provided and this report is for 68 year old patient.After surgery acuity 1 was perfect for her, but 2 weeks later she came in due to sudden loss of vision in the operated eye le.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.The product investigation could not identify a root cause for the reported complaint.The product was not returned.No issues were reported during the lens delivery.It is unknown how the iol would contribute to this event.After surgery.(b)(6) 2023, the patient's acuity 1 was perfect.Two weeks later patient came in due to sudden loss of vision in the operated eye.Irvine gass syndrome, also known as cystoid macular edema (cme), is a notable complication that can occur after any cataract surgery.The primary cause of irvine¿gass syndrome is usually linked to surgical trauma incurred during cataract surgery.This can inadvertently lead to the disruption of the blood-retinal barrier, increasing the permeability of capillaries in the macula, and subsequently causing fluid accumulation.Inflammation plays a crucial role in the development of this syndrome.The surgical trauma triggers an inflammatory response as part of the body's natural healing process.In the case of irvine¿gass syndrome, pro-inflammatory mediators like cytokines are released, leading to vasodilation and increased vascular permeability in the retina.This, in turn, allows fluid to accumulate in the macular region, causing the characteristic symptoms of the syndrome.Individuals with a history of retinal conditions, uveitis, or diabetic retinopathy may be at higher risk.Surgeries that are complicated or lengthy can cause more trauma to the eye, increasing the risk of developing the syndrome.The use of certain medications, like prostaglandin analogs, may exacerbate the condition.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19726448
• Report Number: 1119421-2024-01306
• Device Sequence Number: 18215434
• Product Code: POE
• UDI-Device Identifier: 00380652422116
• UDI-Public: (01)00380652422116(17)260711(11)210713(10)15228609(21)15228609050
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2026
• Device Model Number: DFT415
• Device Lot Number: 15228609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown